An increased risk of a hard or ‘no deal Brexit?

A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.

The delay was announced just a day before Parliament was due to decide whether to accept the draft framework agreement negotiated with the EU over the past 2 years. The deal as it currently stands faces strong opposition, and most observers had predicted it would not pass.

The vote, now set to take place in mid-January, would provide some clarity on how the development, manufacture and sale of pharmaceuticals and medical devices would be regulated after Brexit.

Whether the agreement can be renegotiated remains to be seen so at present there is an increased risk of a hard or ‘no deal Brexit where the UK potentially withdraws from the EU without a trading agreement.

A ‘no deal’ Brexit, if it happens – the European Court of Justice (ECJ) confirmed the UK can halt the Article 50 process unilaterally before 29 March – is predicted by many experts to risk huge social and economic impact.

It will also change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.

Supply chain disruption

Medicine supply chains between the UK and EU will be affected according to the Association for British Pharmaceutical Industries’ (ABPI) chief exective, Mike Thompson.

Writing in response to a government update he said: “Pharmaceutical companies continue to do everything in their power to make sure that patients get access to medicines whatever the Brexit scenario. This includes duplicating processes, changing supply routes and stockpiling medicines in line with the Government’s guidance. However, we have been clear that there are things which are out of our control.

“This update on potential border delays for 6 months in a ‘no deal’ scenario is stark. Stockpiling more medicines is not the solution to this problem,” Thompson continued, adding, “We welcome the Secretary of State’s intention to prioritise the flow of medicines and vaccines. But with just 16 weeks until the UK leaves the EU, we need the detail.”

He urged the Government to take immediate action to open up alternative supply routes between the UK and Europe and tell companies so they can make plans.

Third country controls

The UK BioIndustry Association raised similar concerns, noting the government has provided little information on actions it is planning beyond ensuring there is sufficient roll-on, roll-off freight capacity and that medicines will be prioritised on alternative routes.

It wrote: “A ‘no deal’ Brexit would mean the biggest dis-integration of the complex regulated medicines market across Europe in terms of regulation, cross border movement of goods, comparative pricing and intellectual property. The organisation also pointed out that many key parts of the UK’s future trading relationship will be decided in Brussels.

“The European Commission has made it clear that, in the event of a ‘no deal’ scenario, it will impose full third country controls on people and goods entering the EU from the UK. Whether this happens or not is in their hands, not ours,” it said.

Regulatory uncertainty

Regulations covering the development, manufacture and assessment of pharmaceutical products will also change under a ‘no-deal’ Brexit. It is not clear which EU rules will be written into UK law. For example, new on-pack safety feature regulations are likely to apply, but parts of the EU Clinical Trial Regulation (CTR) may not, according to the European Commission

Neither is it certain how the Medicines and Healthcare products Regulatory Agency (MHRA) will interact with the European Medicines Agency (EMA) with respect to, among other activities, manufacturing facility inspections.

Previously, the UK regulator has been very visible in Europe, ensuring that EU regulations have been pragmatic, favourable to innovation and forward-looking while protecting patient interests.

Other key questions remain regarding pharmacovigilance activities – which must take place in an EU member state or EEA territory – as well as batch release and certification.

RAPS is closely monitoring this period of uncertainty and transition and is committed to informing regulatory professionals with the latest news and insights as they develop.